Response testing for conscious sedation utilizing a non-ear-canal-contacting speaker

ABSTRACT

A conscious sedation system and a request assembly for a response testing apparatus for a conscious sedation system. The conscious sedation system includes a controller which generates a request for a predetermined response from a patient and which analyses at least a response made by the patient to the request to determine a level of sedation of the patient. The response testing apparatus includes a request assembly and a response assembly. The request assembly audibly communicates to the patient the request generated by the controller and includes a non-ear-canal-contacting speaker. The response assembly senses the response and communicates the response to the controller.

FIELD OF THE INVENTION

The present invention relates generally to conscious sedation systems,and more particularly to a conscious sedation system having a responsetesting apparatus and to a request assembly for a response testingapparatus for a conscious sedation system.

BACKGROUND OF THE INVENTION

Known conscious sedation systems include a conscious sedation systemdisclosed in U.S. Patent Application Publication No. 2002/0017299. Inthat system, a controller generated a request for a predeterminedresponse from a patient. The request was in the form of an auditorycommand which was received by a patient through an earphone in the earof the patient or was in the form of a vibration signal which wasreceived by the patient through a vibrator in a handpiece which wasattached to the hand of the patient. The predetermined response to therequest was the pushing of a button on the handpiece by the patientwhich closed a switch sending a signal to the controller. The controlleranalyzed medical information from the patient (such as blood pressureand other information) and analyzed the time delay between the requestand the response to determine a level of sedation of the patient. Whenthe time delay between the request and the response increased, thecontroller determined that the patient was in a deeper level of sedationand decreased the flow of a conscious sedation drug to the patient. Itis known to have a number of volume settings for the auditory commandand to initially manually raise the volume setting before the start ofconscious sedation until a fully conscious patient says he or she canhear the auditory command. It is also known that doctors using a similarsystem have themselves asked the patient by name to squeeze thehandpiece.

What is needed is an improved conscious sedation system and/or componentthereof and/or method therefor. This invention addresses those needslacking in known conscious sedation systems and/or components thereofand/or methods therefor.

SUMMARY OF THE INVENTION

A first expression of a first embodiment of the invention is for aconscious sedation system including a controller and a response testingapparatus. The controller generates a request for a predeterminedresponse from a patient and analyses at least a response made by thepatient to the request to determine a level of sedation of the patient.The response testing apparatus includes a request assembly and aresponse assembly. The request assembly audibly communicates to thepatient the request generated by the controller and includes anon-ear-canal-contacting speaker. The response assembly senses theresponse and communicates the response to the controller.

A second expression of a first embodiment of the invention is for arequest assembly for a response testing apparatus for a conscioussedation system, wherein the conscious sedation system includes acontroller which generates a request for a predetermined response from apatient. The request assembly includes a non-ear-canal-contactingspeaker which audibly communicates to the patient the request generatedby the controller.

The present invention has, without limitation, application in conscioussedation systems used during the performance of medical procedures suchas colonoscopies, robotic-assisted surgery, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1-1 is a schematic diagram of a first embodiment of a first aspectof the present invention showing a conscious sedation system including acontroller and including a response testing apparatus which includes arequest assembly and a response assembly and which uses cablelesscommunication;

FIG. 1-2 is a side-elevational view of an example of a part of therequest assembly of FIG. 1-1 in the form of an auditory requestassembly;

FIG. 1-3 is a front-elevational view of an example of a part of therequest assembly of FIG. 1-1 in the form of a vibratory requestassembly;

FIG. 1-4 is a front-elevational view of an example of a part of theresponse assembly of FIG. 1-1 in the form of a switch response assembly;

FIG. 2-1 is a schematic diagram of a first embodiment of a second aspectof the present invention showing a conscious sedation system including acontroller, a cannula, and a response testing apparatus which includes arequest assembly supported by the cannula and which includes a responseassembly;

FIG. 2-2 is a perspective view of an example of the cannula of FIG. 2-1without the supported request assembly;

FIG. 2-3 is a schematic diagram of a second embodiment of a secondaspect of the present invention showing a conscious sedation systemincluding a controller, a cannula, and a response testing apparatuswhich includes a request assembly and which includes a response assemblysupported by the cannula;

FIG. 2-4 is an enlarged schematic diagram of the response assembly and aportion of the cannula of FIG. 2-3;

FIG. 2-5 is a schematic diagram of a third embodiment of a second aspectof the present invention showing a conscious sedation system including acontroller and including a response testing apparatus which includes arequest assembly and which includes a cannula which is also used as aresponse assembly;

FIG. 3-1 is a graph of a vibration set comprising vibratory pulsesutilizing predetermined time intervals between pulses in applying thevibration stimuli;

FIG. 3-2 is a graph of a vibration set comprising vibratory pulsesutilizing predetermined duration of pulses in applying the vibrationstimuli;

FIG. 3-3 is a schematic diagram of an embodiment of a third aspect ofthe present invention showing a conscious sedation system including acontroller and including a response testing apparatus which includes arequest assembly and a response assembly;

FIG. 3-4 is a block diagram of an embodiment of the method of thepresent invention using the conscious sedation system;

FIG. 4-1 is a schematic diagram of a first embodiment of a fourth aspectof the present invention showing a conscious sedation system including acontroller and including a response testing apparatus which includes arequest assembly and a response assembly;

FIG. 4-2 is a front-elevational view of an example of the responseassembly of FIG. 4-1 in the form of a handpiece;

FIG. 4-3 is a schematic diagram of the handpiece of FIG. 4-2 includingthree mutually orthogonal accelerometers;

FIG. 4-4 is a front-elevational view of another example of the responseassembly of FIG. 4-1 in the form of a telemetry tracking system;

FIG. 4-5 is a top planar view of an additional example of the responseassembly of FIG. 4-1 in the form of a touch pad;

FIG. 5-1 is a schematic diagram of a first embodiment of a fifth aspectof the present invention showing a conscious sedation system including acontroller and including a response testing apparatus which includes arequest assembly and a response assembly;

FIG. 5-2 is a front-elevational view of an example of the responseassembly of FIG. 4-1 in the form of a handpiece;

FIG. 5-3 is a schematic diagram of the handpiece (without the band) ofFIG. 5-2 including a finger or thumb actuated plunger and including aforce sensor;

FIG. 5-4 is a schematic view a different handpiece which includes aresistance sensor;

FIG. 5-5 is a schematic view of a different handpiece which includes acapacitance sensor;

FIG. 5-6 is a schematic view of a different handpiece which includes acompliant air bladder;

FIG. 6-1 is a schematic diagram of a first embodiment of a sixth aspectof the present invention showing a conscious sedation system including acontroller and a response testing apparatus, wherein the responsetesting apparatus includes a request assembly and a response assembly,and wherein the request assembly includes a non-ear-canal-contactingspeaker;

FIG. 6-2 is a schematic front elevational view of a first example of therequest assembly of FIG. 6-1 including a speaker which communicates therequest to the patient at least in part by bone conduction;

FIG. 6-3 is a schematic side elevational view of a second example of therequest assembly of FIG. 6-1 including a speaker disposed in a pillow;

FIG. 6-4 is a schematic perspective view of a third example of therequest assembly of FIG. 6-1 including a speaker disposed on the outsideof a skull cap worn by the patient;

FIG. 6-5 is a schematic perspective view of a fourth example of therequest assembly of FIG. 6-1 including a speaker connectable by a soundtube to the outside of a skull cap worn by the patient;

FIG. 6-6 is a cross sectional view of a portion of the skull cap and aportion of the sound tube of FIG. 6-5 connected to the skull cap;

FIG. 7-1 is a schematic diagram of an embodiment of a seventh aspect ofthe present invention showing a conscious sedation system including acontroller having an input for including a personalized message and aresponse testing apparatus which includes a request assembly and aresponse assembly;

FIG. 8-1 is a schematic diagram of an embodiment of an eighth aspect ofthe present invention showing a conscious sedation system including acontroller and including a response testing apparatus which includes arequest assembly and a response assembly, wherein the response and/orrequest assembly is a finger movement response assembly;

FIG. 8-2 is an embodiment of a finger movement response assembly in theform of a finger touch response apparatus;

FIG. 8-3 is another embodiment of a finger movement response assembly inthe form of a handpiece sensor mechanism;

FIG. 9-1 is a schematic diagram of an embodiment of a ninth aspect ofthe present invention showing a conscious sedation system including acontroller programmed to calibrate a patient's level of hearing and aresponse testing apparatus which includes a request assembly and aresponse assembly;

FIG. 9-2 is a block diagram of an embodiment of the method of thepresent invention using the conscious sedation system involvingautomated audio calibration;

FIG. 9-3 is a block diagram of another embodiment of the method of thepresent invention using the conscious sedation system automated audiocalibration and determining the level of sedation in a patient; and

FIG. 9-4 is a schematic diagram of an embodiment of the presentinvention showing a response testing apparatus including asub-controller programmed to calibrate a patient's level of hearing, theresponse testing apparatus which includes a request assembly and aresponse assembly.

DETAILED DESCRIPTION OF THE INVENTION

Before explaining the present invention in detail, it should be notedthat the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The illustrative embodiments ofthe invention may be implemented or incorporated in other aspects,embodiments, variations and modifications, and may be practiced orcarried out in various ways. Furthermore, unless otherwise indicated,the terms and expressions employed herein have been chosen for thepurpose of describing the illustrative embodiments of the presentinvention for the convenience of the reader and are not for the purposeof limiting the invention.

It is understood that any one or more of the following-describedaspects, embodiments, expressions of embodiments, examples, methods,etc. can be combined with any one or more of the otherfollowing-described aspects, embodiments, expressions of embodiments,examples, methods, etc. For example, and without limitation, cablelesscommunication can be used in combination with personalized audiorequests, etc.

It is also understood that while the following systems, methods, etc.apply to conscious sedation, such systems, methods, etc. have equalapplication to conscious and unconscious sedation with the appropriatechoice of drug(s) and dose rate(s). In one example, such conscious andunconscious sedation system and/or method has the capability to bringthe patient into unconscious sedation, to bring the patient into and outof conscious sedation, and/or to assess the patient as the patient movesinto and out of deep sedation or consciousness. In one illustration, adeep sedation level or unconsciousness is indicated if a patientresponse to a stimuli is not detected. Further, the following discussionof conscious sedation also encompasses the conscious sedation portion ofa system and/or method which provides both conscious and unconscioussedation. It is noted that conscious sedation includes conscioussedation where the patient is not responsive to stimuli (which is alsoknown as deep sedation) and conscious sedation where the patient isresponsive to stimuli.

Conscious Sedation Involving Cableless Communication

A first aspect of the invention relates to conscious sedation andcableless communication. Referring now to the drawings, FIG. 1-1illustrates a first embodiment of the first aspect of the invention. Afirst expression of the first embodiment is for a conscious sedationsystem 100 including a controller 102 and a response testing apparatus104 (wherein parts 104 a, 104 b, 104 c and 104 d are parts of theresponse testing apparatus 104). The controller 102 generates a requestfor a predetermined response from a patient 106 and analyses at least aresponse made by the patient 106 to the request to determine a level ofsedation of the patient 106. The response testing apparatus 104 includesa request assembly 108 (wherein parts 108 a and 108 b are parts of therequest assembly 108) and a response assembly 110 (wherein parts 110 aand 110 b are parts of the response assembly 110). The request assembly108 communicates to the patient 106 the request generated by thecontroller 102. The response assembly 110 senses the response andcommunicates the response to the controller 102. At least one of therequest assembly 108 and the response assembly 110 includes a cablelesscommunication device 112 and 113 (wherein parts 112 a and 112 b areparts of the cableless communication device 112 and parts 113 a and 113b are parts of the cableless communication device 113) whichcommunicates at least one of the request and the response between thecontroller 102 and the patient 106.

Examples of cableless communication devices 112 and 113 include, withoutlimitation, communication devices using: a radio frequency (RF)transmitter and receiver (such as those operating in the range of 0.1mega hertz to 3 giga hertz), an ultrasonic transmitter and receiver, aninfrared transmitter and receiver, and/or a visible-light transmitterand receiver, etc. Such cableless communication devices are known to theartisan.

In one implementation of the first expression of the embodiment of FIG.1-1, certain patient vital signs such as blood pressure, blood oxygensaturation (oximetry) and inhalation and exhalation carbon dioxidelevels (capnometry) are electronically monitored (not shown in FIG. 1-1)and are also analyzed by the controller 102, in addition to the responsefrom the response assembly 110, to determine a level of sedation of thepatient. The term “controller”, without limitation, includes onecontroller and includes two or more spaced-apart subcontrollers, etc.

In one example of the first expression of the embodiment of FIG. 1-1, auser and/or the controller 102 determines a delivery schedule (includingany interruption of delivery) of a conscious-sedation drug to thepatient 106 based at least in part on the determined level of sedationof the patient 106. The drug delivery apparatus has been omitted fromFIG. 1-1 for clarity. A conscious sedation drug is a drug or drugcombination which, in an efficacious amount, is capable of sedating thepatient 106 during a medical procedure (such as a colonoscopy) whilekeeping the patient 106 conscious. Conscious sedation drugs, such asPropofol, are well known in the medical art. In one alternative, a usersuch as a doctor, instead of the controller 102, determines a deliveryschedule of the conscious-sedation drug to the patient 106 based atleast in part on the determined level of sedation of the patient 106.

In the same or a different example, the cableless communication device112 and 113 includes a transmitter 114 and 115 and a receiver 116 and117 in cableless communication with the transmitter, and the cablelesscommunication device 112 and 113 imposes a unique identifier on at leastone of the transmitter 114 and 115 and the receiver 116 and 117 whichprevents the cableless communication device 112 and 113 from respondingto crosstalk from other transmitters. In one illustration, the uniqueidentifier is manually-triggered, is automatically proximity-triggeredwhen the transmitter and the receiver are brought into proximity to eachother, or requires both manual and proximity triggering. In onevariation, the transmitter 114 and 115 is an RF transmitter 118 and 119,and the receiver 116 and 117 is an RF receiver 120 and 121 in wirelesscommunication with the RF transmitter 118 and 119. In one modification,the cableless communication device 112 and 113 selects the operatingfrequency of at least one of the RF transmitter 118 and 119 and the RFreceiver 120 and 121 which prevents the cableless communication device112 and 113 from responding to crosstalk from other transmitters. Inanother modification, the cableless communication device 112 and 113selects a digital code for at least one of the RF transmitter 118 and119 and the RF receiver 120 and 121 which prevents the cablelesscommunication device 112 and 113 from responding to crosstalk from othertransmitters. In one implementation, the unique identifier is aproximity-triggered unique identifier imposed when the RF transmitter118 and 119 and the RF receiver 120 and 121 are brought into proximityto each other. In another implementation, the imposing of the uniqueidentifier does not take place automatically with proximity but requires(in addition to proximity manual activation, such as pushing of a pushbutton, to impose the unique identifier. The unique identifier can beerased after a period of inactivity or by manual deactivation at the endof the medical procedure. Such imposing of unique identifiers, includingproximity imposing of unique identifiers, is within the capabilities ofone of ordinary level of skill in the art. An example of technologywhich uses proximity imposing of unique identifiers is a gas pump wavecard used by drivers at some service stations to pay for gasoline.Alternately, the unique identifiers can be manually set (without regardto proximity). Other techniques to eliminate or reduce crosstalk includereducing the power output of the transmitter such that only a receiverin proximity to the transmitter will respond to the transmitter and/orinclude directional transmission and/or directional reception.

In one configuration of the first expression of the embodiment of FIG.1-1, the conscious sedation system 100 also includes a console 122,wherein the controller 102 is disposed in the console 122. In onevariation, the console 122 is a procedure room console designed to stayin the medical procedure room. In another variation, the console 122 isa bedside console designed to be transported with the occupied hospitalbed to the medical procedure room. In a further variation, the consolehas a first subconsole designed to stay in the medical procedure roomand a second subconsole designed to be a bedside console. It is notedthat a bedside console is disposed proximate the patient. In oneconfiguration, the cableless communication takes place directly betweena procedure room console and the patient. In another configuration, thecableless communication takes place directly between a procedure roomconsole and a bedside console (with cable communication between thebedside console and the patient). In a further configuration, thecableless communication takes place directly between the bedside consoleand the patient. Other configurations are left to the artisan.

A second expression of the embodiment of FIG. 1-1 is for a responsetesting apparatus 104 for a conscious sedation system 100. The responsetesting apparatus 104 includes a request assembly 108 and a responseassembly 110. The request assembly 108 communicates to a patient 106 arequest generated by a controller 102 of the conscious sedation system100 for a predetermined response from the patient 106. The responseassembly 110 senses a response made by the patient 106 to the requestand communicates the response to the controller 102 which analyses atleast the response to determine a level of sedation of the patient 106.At least one of the request assembly 108 and the response assembly 110includes a cableless communication device 112 and 113 which communicatesat least one of the request and the response between the controller 102and the patient 106.

In one example of the second expression of the embodiment of FIG. 1-1,the request assembly 108 includes a cableless communication device 112which communicates the request from the controller 102 to the patient106. In one variation, the cableless communication device 112 includesan RF transmitter 118 and includes an RF receiver 120 in wirelesscommunication with the RF transmitter 118 and disposed proximate thepatient 106. In one modification, the request assembly 108 verifies thatthe request was received by the RF receiver 120 (such as by using anaccelerometer or a switch indicating a request in the form of vibrationfrom a vibrator has been received or such as by using a microphoneindicating a request in the form of a sound from a speaker has beenreceived and sending a verification signal back to the controller) as iswithin the capabilities of the artisan. In the same or a differentmodification, the request assembly 108 includes a battery-operatedportion 124, and the request assembly 108 monitors the battery conditionof the battery-operated portion 124. It is noted that the term “battery”includes a cell and a series of cells.

In one implementation of the request assembly 108, the request assembly108 is an auditory request assembly 126 as shown in FIG. 1-2. Theaudible request assembly 126 includes a speaker 128, and the RF receiver120 (omitted from FIG. 1-2 for clarity) is used to activate the speaker126 to produce an audible request to the patient 106. In one variation,the speaker 128 is an earphone 130 (such as one which clips on an earlobe) disposable proximate an ear of the patient 106. In onemodification, the RF receiver 120 is disposed within or on the earphonehousing. In another modification, the RF receiver is disposed on aheadset and the RF receiver is wired to the earphone which is supportedby the headset.

In another implementation of the request assembly 108, the requestassembly 108 is a vibratory request assembly 132 as shown in FIG. 1-3.The vibratory request assembly 132 includes a vibrator 134, and the RFreceiver 120 (omitted from FIG. 1-3 for clarity) is used to activate thevibrator 134 to produce a tactile request to the patient 106. In onevariation, the vibrator 134 is disposed in a handpiece 136, and thehandpiece 136 is disposable proximate a hand of the patient 106.

In the same or a different example of the second expression of theembodiment of FIG. 1-1, the response assembly 110 includes a cablelesscommunication device 113 which communicates the response from thepatient 106 to the controller 102. In one variation, the cablelesscommunication device 113 includes a transmitter 115 which is an RFtransmitter 119 disposed proximate the patient 106 and includes areceiver 117 which is an RF receiver 121 in wireless communication withthe RF transmitter 119. In one modification, the response assembly 110verifies that the response was received by the RF receiver 121 as iswithin the capabilities of the artisan. In the same or a differentmodification, the response assembly 110 includes a battery-operatedportion 125, and the response assembly 110 monitors the batterycondition of the battery-operated portion 125.

In one implementation of the response assembly 110, the responseassembly 110 is a switch response assembly 138 as shown in FIG. 1-4. Theswitch response assembly 138 includes a handpiece 140 disposableproximate a hand of the patient 106. The handpiece 140 includes a switch142, and the response includes the patient 106 activating the switch 142whereby a signal is sent by the RF transmitter 119 (omitted from FIG.1-4 for clarity). In one variation, the handpiece 140 and the handpiece136 are the same handpiece which includes both the vibrator 134 and theswitch 142.

In one configuration of the second expression of the embodiment of FIG.1-1, the request assembly 108 includes a cableless communication device112 which communicates the request from the controller 102 to thepatient 106, and the response assembly 110 includes a cablelesscommunication device 113 which communicates the response from thepatient 106 to the controller 102. In one variation, the transmitter 114of the cableless communication device 112 of the request assembly 108 isdisposed on or in the console 122, and the receiver 117 of the cablelesscommunication device 113 of the response assembly 110 is disposed on orin the console 122.

A third expression of the embodiment of FIG. 1-1 is a response testingapparatus 104 for a conscious sedation system 100. The response testingapparatus 104 includes a request assembly 108 and a response assembly110. The request assembly 108 communicates to a patient 106 a requestgenerated by a controller 102 of the conscious sedation system 100 for apredetermined response from the patient 106. The response assembly 110senses a response made by the patient 106 to the request andcommunicates the response to the controller 102 which analyses at leastthe response to determine a level of sedation of the patient 106. Atleast one of the request assembly 108 and the response assembly 110includes a cableless communication device 112 and 113 which communicatesat least one of the request and the response between the controller 102and the patient 106. The cableless communication device 112 and 113includes a transmitter 114 and 115 and a receiver 116 and 117 incableless communication with the transmitter 114 and 115. The cablelesscommunication device 112 and 113 imposes a unique identifier on at leastone of the transmitter 114 and 115 and the receiver 116 and 117 whichprevents the cableless communication device 112 and 113 from respondingto crosstalk from other transmitters.

In one example of the third expression of the embodiment of FIG. 1-1,the unique identifier (which in one option includes the serial number ofone or more components) is a proximity-triggered unique identifierimposed when the transmitter 114 and 115 and the receiver 116 and 117are brought into proximity to each other. In one variation, thetransmitter 114 and 115 is an RF transmitter 118 and 119, and thereceiver 116 and 117 is an RF receiver 120 and 121 in wirelesscommunication with the RF transmitter 118 and 119. In one modification,the cableless communication device 112 and 113 selects the operatingfrequency of at least one of the transmitter 114 and 115 and thereceiver 116 and 117 which prevents the cableless communication device112 and 113 from responding to crosstalk from other transmitters. Inanother modification, the cableless communication device 112 and 113selects a digital code for at least one of the transmitter 114 and 115and the receiver 116 and 117 which prevents the cableless communicationdevice 112 and 113 from responding to crosstalk from other transmitters.In one application, the user verifies that the imposition of the uniqueidentifier has been successful before use with a patient. In onevariation, there is also included a lockout which prevents use of thecableless communication device unless the imposition of the uniqueidentifier has been successfully verified.

Advantages and benefits of one or more of the expressions of theembodiment of FIG. 1-1 include elimination of cables in the medicalprocedure room which allows the medical procedure (including surgery) tobe performed with less wiring clutter between the patient 106 and theconsole 122. Cableless communication means the patient is less likely tobecome entangled in cords and means greater reliability due to fewerconnections. Cableless communication provides for easier user setup asno cable connections need be made. It is noted that it is easier todesign equipment to meet electrical safety requirements using cablelesscommunication than using cables. In the unique identifier example,imposing unique identifiers allows, in one implementation, any handpiece136 and 140 to be used with any console 122.

Conscious Sedation Involving a Cannula

A second aspect of the invention relates to conscious sedation andinvolves a cannula. A cannula is a well known medical device which isused for monitoring the breathing of a patient and which is placed onthe face of the patient proximate the nose and/or mouth of the patient.Referring now to the drawings, FIG. 2-1 illustrates a first embodimentof the second aspect of the invention. A first expression of the firstembodiment is for a conscious sedation system 200 including a controller202, a cannula 204, and a response testing apparatus 206 (wherein parts206 a and 206 b are parts of the response testing apparatus 206). Thecontroller 202 generates a request for a predetermined response from apatient 208 and analyses at least a response made by the patient 208 tothe request to determine a level of sedation of the patient 208. Thecannula 204 is disposable on the face of the patient 208 proximate atleast one of the nose and the mouth of the patient 208 for monitoringthe breathing of the patient. The response testing apparatus 206includes a request assembly 210 and a response assembly 212. The requestassembly 210 communicates to the patient 208 the request generated bythe controller 202. The response assembly 212 senses the response andcommunicates the response to the controller 202. At least a part of atleast one of the request and response assemblies 210 and 212 issupported by the cannula 204. The terminology “supported by the cannula”means supported at least in part by the cannula.

An example of a cannula 204 is shown in FIG. 2-2 wherein the cable/tube214 operatively connecting the cannula 204 to the controller 202 hasbeen removed. The headband 216 of the cannula 204 is used to secure thecannula 204 on the face of the patient 208. In one use, the cannula 204is used to monitor the inhalation and exhalation carbon dioxide levels(capnometry) of the patient 208 and/or the pressure of the patient'sinhalation and exhalation and optionally delivers oxygen to the patient.It is noted that at least a part of the request assembly 210 issupported by the cannula 204 in the first embodiment shown in FIG. 2-1.

In one implementation of the first expression of the embodiment of FIG.2-1, certain patient vital signs such as blood pressure, blood oxygensaturation (oximetry) and inhalation and exhalation carbon dioxidelevels (capnometry) are electronically monitored and are also analyzedby the controller 202, in addition to the response from the responseassembly 212, to determine a level of sedation of the patient. The term“controller”, without limitation, includes one controller and includestwo or more spaced-apart subcontrollers, etc. An example of a responseassembly 212 in FIG. 2-1 is a handpiece which has a switch and which issecured to the hand of the patient 208. Other examples include a chestband to monitor a deep breath.

In one example of the first expression of the embodiment of FIG. 2-1, auser and/or the controller 202 determines a delivery schedule (includingany interruption of delivery) of a conscious-sedation drug to thepatient 208 based at least in part on the determined level of sedationof the patient 208. The drug delivery apparatus has been omitted fromFIG. 2-1 for clarity. A conscious sedation drug is a drug or drugcombination which, in an efficacious amount, is capable of sedating thepatient 208 during a medical procedure (such as a colonoscopy) whilekeeping the patient 208 conscious. Conscious sedation drugs, such asPropofol, are well known in the medical art. In one alternative, a usersuch as a doctor, instead of the controller 202, determines a deliveryschedule of the conscious-sedation drug to the patient 208 based atleast in part on the determined level of sedation of the patient 208.

In the same or a different example, the request assembly 210 includes afirst vibrator 218 supported by the cannula 204. In one variation, thefirst vibrator 218 produces a tactile request to the face of the patient208. In one modification, the first vibrator 218 is disposed in thecannula 204. The terminology “disposed in the cannula” means disposed atleast in part in the cannula. In a different modification, the firstvibrator 218 is disposed on the cannula 204. In one arrangement, therequest assembly 210 includes a second vibrator 220 disposable toproduce a tactile request to a site on the patient 208 other than to theface of the patient 208. In one application, the controller 202 at leastcompares responses of the patient to tactile requests from the first andsecond vibrators 218 and 220 in determining the level of sedation of thepatient. In another arrangement, the first vibrator 218 is the onlyvibrator of the request assembly 210 producing a tactile request.

A second embodiment of the second aspect of the present invention is fora conscious sedation system 222 and is shown in FIGS. 2-3 and 2-4. In afirst expression of the second embodiment, the conscious sedation system222 includes a controller 224, a cannula 226, and a response testingapparatus 228 (wherein parts 228 a and 228 b are parts of the responsetesting apparatus 228). The response testing apparatus 228 includes arequest assembly 230 and includes a response assembly 232. At least apart of the response assembly is supported by the cannula 226.

In one implementation of the second embodiment, the predeterminedresponse is a patient 208 head-generated response. In one variation, thepatient 208 head-generated response is a patient-generated vocalresponse, and the response assembly 232 includes a sound detector 234(such as a microphone) supported by the cannula 226. In onemodification, the controller 224 at least uses at least one of theintensity and the tonal qualities of the vocal response in determiningthe level of sedation of the patient 208. In another variation, thepatient 208 head-generated response is a patient-generated head movementresponse, and the response assembly 232 includes a motion sensor 236supported by the cannula 226. In a further variation, the patient 208head-generated response is a patient-generated breathing response, andthe response assembly 232 includes a breathing sensor 238 (such as apressure sensor) and/or a breathing-detection tube supported by thecannula 226. In one illustration employing a breathing-detection tube,the breathing sensor is operatively connected to the tube and is locatedremote from the cannula. In one modification, the patient-generatedbreathing response includes at least one of a yawn and a breath deeperthan an immediate previous breath. In the same or a differentmodification, the breathing sensor 238 detects the pressure of theexhaled breathing of the patient 208. Examples of request assemblies 230in FIG. 2-3 include a handpiece having a vibrator and secured to thehand of the patient 208 and an earphone speaker disposed in the ear ofthe patient 208. Other request assemblies include vibrators supported bya blood pressure cuff, supported by a pulse oximeter disposable on afinger or ear lobe of the patient, or supported by another medicaldevice. Additional request assemblies include vibrators placed upon theface, head, neck, or upper spine of the patient.

In one configuration, not shown, the cannula supports at least a part ofthe request assembly and at least a part of the response assembly. Inone example, the first vibrator 218 and at least one of the sounddetector 234, the motion sensor 236, and the breathing sensor 238 aresupported by the same cannula.

An alternate expression of either or both of the first and secondembodiments of the second aspect of the invention, which will bedescribed for simplicity using only the part numbers of the firstembodiment of FIG. 2-1, is for a cannula and response testing assemblage240 (wherein parts 240 a and 240 b are parts of the response testingassemblage 240) for a conscious sedation system 200. The cannula andresponse testing assemblage 240 includes a cannula 204 and includes aresponse testing apparatus 206. The cannula 204 is disposable on theface of a patient 208 proximate at least one of the nose and the mouthof the patient 208 for monitoring the breathing of the patient. Theresponse testing apparatus 206 includes a request assembly 210 and aresponse assembly 212. The request assembly 210 communicates to thepatient 208 a request generated by a controller 202 of the conscioussedation system 200 for a predetermined response from the patient 208.The response assembly 212 senses a response made by the patient 208 tothe request and communicates the response to the controller 202 whichanalyses at least the response to determine a level of sedation of thepatient 208. At least a part of at least one of the request and responseassemblies 210 and 212 is supported by the cannula 204.

In one example of the cannula and response testing assemblage 240, therequest assembly includes a first vibrator 218 supported by the cannula204. In the same or a different example, the response is a patient 208head-generated response, and at least a part of the response assembly issupported by the cannula. In one variation, the response assemblyincludes at least one of a sound detector, a motion sensor, a breathingsensor, and a breathing-detection tube supported by the cannula.

A third embodiment of the second aspect of the present invention is fora conscious sedation system 242 and is shown in FIG. 2-5. The conscioussedation system 242 includes a controller 244 and a response testingapparatus 246 (wherein parts 246 a and 246 b are parts of the responsetesting apparatus 246). The controller 244 generates a request for apredetermined breathing response from a patient 208 and analyses atleast a breathing response made by the patient 208 to the request todetermine a level of sedation of the patient 208. The response testingapparatus 246 includes a request assembly 248 and a cannula 250. Therequest assembly 248 communicates to the patient 208 the requestgenerated by the controller 244. The cannula 250 is disposable on theface of the patient 208 proximate at least one of the nose and the mouthof the patient 208 for monitoring the breathing of the patient 208,wherein the cannula 250 is operatively connected to the controller 244.

In one example of the third embodiment, a user and/or the controller 244determines a delivery schedule (including any interruption of delivery)of a conscious-sedation drug to the patient 208 based at least in parton the determined level of sedation of the patient 208.

It is noted that unnumbered lines in the figures which emanate from thecontroller 202, 224, and 244 are connecting cables/tubes as isunderstood by those skilled in the art.

In one employment, the controller analyses the sound intensity and/ortonal qualities of the sound response for use in determining the levelof sedation of the patient. Examples include predetermined vocal soundswhich include one or more words, phrases, sighs, yawns, groans, etc.Baseline vocal sound responses from the patient before the start ofsedation may be used to train the controller 244 to recognize vocalsound responses from the patient before and during patient sedation.Advantages of a vocal sound response include such a response beingeasier to make for a more deeply sedated patient than activating aswitch on a handpiece. Also, some patients due to infirmity, physicalhandicap, etc. may be able to make a vocal response but be unable toactivate a switch on a handpiece.

Advantages and benefits of one or more of the expressions of theembodiments of FIGS. 2-1 to 2-5 include elimination of an independentsupport for at least a part of the request assembly and/or the responseassembly of the response testing apparatus by making dual use of thecannula when a cannula is used in a conscious sedation system. In thevibrator request example, a vibratory tactile request to the face of apatient is easier for a more deeply sedated patient to perceive (as theface is more sensitive to touch) than a vibratory tactile request to thehand of a patient. In the patient head-generated response example, apatient made sound, head movement, or breathing response to a requestfrom the controller is easier for a more deeply sedated patient to makethan activating a switch on a handpiece.

In an expansion of the second aspect of the invention, the response is apatient made vocal sound, and the response assembly is not limited tobeing supported by the cannula. In this expanded second aspect of theinvention, the sound detector need only be able to detect patient madevocal sounds. The type of sound detector is left to the artisan. In oneexample, a microphone is disposable proximate the mouth of the patient.In one application, the microphone is disposed on the hospital bedproximate the face of the patient. In another application, themicrophone is disposed on a bedside stand. In a further application, themicrophone is disposed on the patient or the patient's hospital gown.Other applications are left to the artisan. In another example, a soundtube extends from proximate the patient's face to a remotely-locatedsound detector. In a further example, the microphone picks up patientmade sounds by bone conduction. Other examples are left to the artisan.

Time Variant Vibration Stimulus Response for a Conscious Sedation System

A third aspect of the invention relates to conscious sedation and theapplication of discrete vibration pulses to determine the level ofsedation in a patient. The invention is a system and method of applyingdiscrete vibration pulses and altering the time intervals between pulsesand the duration of the pulses to determine the level of sedation in apatient. In the prior art, the level of sedation in a patient isdetermined by applying a vibration stimuli to the sedated patient andassessing the patient's response to the stimuli. If the patient does notrespond, the intensity of the stimuli is increased until the patientresponds to the stimuli. The intensity of the stimuli required togenerate the patient's response is correlated with the patient's levelof sedation. One disadvantage in this method is that the level ofintensity required to generate a response from the patient may beextremely high. In the case of a handpiece, the vibration stimuli may beso intense that it is difficult for the sedated patient to hold onto to,let alone, respond to the stimuli by squeezing the handpiece.

Accordingly, in one embodiment of the present invention, a method fordetermining the level of sedation in a patient utilizes the timeinterval of the vibration stimuli thereby obviating the need to use theintensity stepping approach used in the prior art. In essence, thepatient's ability to discern vibratory time-dependent patterns can beused to determine the patient's level of sedation. For example, in atime interval analysis, a set of vibration stimuli comprises severalvibratory pulses which are applied to the patient with a predeterminedtime interval between each pulse. When the patient is not sedated orless sedated, the patient may be able to discern the distinct pulses,whereas when the patient is more sedated, the patient's ability todiscern distinct pulses may be reduced. Referring to FIG. 3-1, a sampleset of three pulses is applied with a predetermined time spaced inbetween each pulse. The time between the first pulse and the secondpulse is T1 and the between the second pulse and third pulse is T2. Aless sedated patient may be able to discern the three individual pulses,whereas when the patient becomes more sedated, he may only recognize twoof the three pulses because of the reduced ability to discern the timeinterval spaced between the pulses. Further, when the patient becomeseven more sedated, his ability to discern the time interval spacedbetween the pulses may be reduced to the extent that the patient is onlyable to discern the set of three pulses as one whole pulse. Thus, thisability to discern the time interval between each distinct pulsecorrelates with the patient's level of sedation. As the patient becomesmore sedated, the greater the time interval is required between eachpulse for the patient to discern the distinct pulses. Accordingly, thetime intervals between the pulses of each set of stimuli may be modifiedto be greater or less for subsequent sets to analyze the patient'sresponse to the sets and to correlate the response to the patient'slevel of sedation. Although the time interval ranges will vary with thepatient, the interval may range from 0.05 to 15.0 seconds. Moretypically, the interval ranges from 0.3 to 1.0 seconds. In oneembodiment of the invention, the range is 0.5 to 0.7 seconds. In onetypical protocol that might be used to monitor sedation, the timeinterval between each pulse may be initiated at about 0.4 seconds. Ifthe patient detects the distinct pulses, the time interval between thepulses is decreased to 0.2 seconds. If the patient does not detect thedistinct pulses, the time interval between the pulses is increased to0.6 seconds.

In another embodiment of the present invention, a method for determiningthe level of sedation in a patient utilizes the duration of the pulsesof the vibration stimuli thereby obviating the need to use the intensitystepping approach used in the prior art. Referring to FIG. 3-2, thevibration set contains three vibratory pulses, wherein each pulse has apredetermined duration D1, D2 and D3. The duration of the pulses in eachset can be the same or different and can be modified to be greater orless in subsequent sets. In essence, the patient's ability to discernthe duration of the vibratory pulses can be used to determine thepatient's level of sedation. For instance, a pulse that is 0.5 second induration may be recognized by a patient who is not sedated or lesssedated but when the patient becomes more sedated, he may not be able todiscern the 0.5 second pulse stimuli but may instead require a pulsewith a longer duration, such as a one second pulse, in order to discernit. Accordingly, the patient's ability to discern a pulse with aprescribed duration can be used to assess the patient's level ofsedation. The greater the duration of the pulse necessary for thepatient to discern the pulse, the more sedated the patient. In a morepreferred embodiment of the invention, the vibratory pulse is a “crisp”or sharp pulse; crisp pulses are more alerting and stimulating and aremore able to evoke a response from the sedated patient. In the priorart, after the vibratory pulse is applied, the pulse glides to a halt,i.e. gradually decreasing from its highest intensity to its lowestintensity. However, in the present invention, the pulses that areapplied are sharp pulses that come to a halt almost immediately, whereinthe time it takes to go from its highest intensity to its lowestintensity is about 0.1 second. This is achieved by employing a brakingdevice such as an electrical brake or a brake clutch to provide promptcessation. Furthermore, the time it takes for the pulse to go from itslowest intensity to its highest intensity is less than about 0.1 second.This enables the request unit to send a crisp pulse of a predeterminedduration to assess the patient's level of sedation. Although theduration ranges of the pulses will vary with the patient, the durationmay range from 0.1 to 15 seconds. More typically, the duration rangesfrom 0.5 to 1.0 seconds. In one embodiment of the invention, the rangeis 0.5 to 1.0 second. In one typical protocol that might be used tomonitor sedation, the duration of each pulse may be initiated at about0.6 second. If the patient detects the distinct pulses, the duration ofthe pulses is decreased to 0.4 second. If the patient does not detectthe distinct pulses, the duration between the pulses is increased to 0.9second.

In another manifestation of the invention, both the time interval andthe duration of the pulse sets may be used in conjunction to assess thepatient's response and determine the level of sedation of the patient. Aset of vibration stimuli comprising vibratory pulses of predeterminedduration for each pulse and predetermined time intervals between eachpulse is applied to the patient. The patient then responds to the set ofvibration stimuli. A subsequent set of vibration stimuli can be appliedto generate a subsequent response by the patient. The subsequent set ofvibration stimuli can be the same or modified from the previous set byeither altering the duration and/or time interval. In yet a furtherembodiment of the invention, the individual vibratory pulses can beintensity modulation or frequency modulation pulses. More specifically,an intensity modulation pulse is a vibratory pulse that has a variableintensity within the individual pulse itself. A frequency modulationpulse is a vibratory pulse that has a variable frequency within theindividual pulse itself. Either intensity and frequency modulationpulses may be incorporated with the time interval between and/orduration of the pulses in order to assess the level of sedation of apatient. An embodiment of a method of the invention as shown in FIG. 3-4comprises applying a first stimuli to a patient who has received, isreceiving or is about to receive a conscious sedation drug, instructingthe patient to respond to the stimuli, monitoring a patient's responseto the stimuli, applying an additional stimuli to the patient when thepatient has received, is receiving or is about to receive a dose of aconscious sedation drug, wherein the additional stimuli can be the sameor different as the first stimuli, monitoring the patient's response tothe additional stimuli, repeating the steps of applying the additionalstimuli and monitoring the patient's response to the additional stimulito determine the patient's level of sedation. Furthermore, the patient'sinitial or previous response may be used as a baseline for comparison tothe present response.

Note that FIGS. 3-1 and 3-2 are only examples vibration sets; thevibration sets can contain any number of pulses and the time intervalbetween each of the pulses T1, T2 and so forth and the duration of eachpulse D1, D2 and so forth can be the same or different and adjusted togreater or less in subsequent sets of vibration stimuli to determine thelevel of sedation of the patient.

Referring to the drawings, FIG. 3-3 illustrates yet another embodimentof the third aspect of the invention. The embodiment is for a conscioussedation system 300 including a controller 302 and a response testingapparatus 304. The controller generates a request for a predeterminedresponse from a patient 306, the request comprising a vibration stimuliset having a vibratory pulses having predetermined time interval(s)between each of the pulses and predetermined duration(s) for each pulse.The controller analyses at least a response generated by the patient 306to the request to determine a level of sedation of the patient 306. Theresponse testing apparatus 304 includes a request assembly 308 and aresponse assembly 310. The request assembly 308 communicates to thepatient 306 the request generated by the controller 302.

In one implementation of the embodiment of FIG. 3-3, certain patientvital signs such as blood pressure, blood oxygen saturation (oximetry)and inhalation and exhalation carbon dioxide levels (capnometry) areelectronically monitored and are also analyzed by the controller 302, inaddition to the response from the response assembly 310, to determine alevel of sedation of the patient. The term “controller”, withoutlimitation, includes one controller and includes two or morespaced-apart subcontrollers, etc. Examples of request assemblies 308 inFIG. 3-3 include a handpiece having a vibrator and secured to the handof the patient 306 and an earphone speaker disposed in the ear of thepatient 306. Other request assemblies include vibrators supported by ablood pressure cuff, supported by a pulse oximeter disposable on afinger or ear lobe of the patient, or supported by another medicaldevice. Additional request assemblies include vibrators placed upon theface, head, neck, or upper spine of the patient.

In one example of the expression of the embodiment of FIG. 3-3, thecontroller 302 determines a delivery schedule of a conscious sedationdrug to the patient 306 based at least in part on the determined levelof sedation of the patient 306. The drug delivery apparatus has beenomitted from FIG. 3-3 for clarity. A conscious sedation drug is a drugor drug combination which, in an efficacious amount, is capable ofsedating the patient 306 during a medical procedure (such as acolonoscopy) while keeping the patient 306 conscious. Conscious sedationdrugs, such as Propofol, are well known in the medical art. In onealternative, a doctor, instead of the controller 302, determines adelivery schedule of the conscious sedation drug to the patient 306based at least in part on the determined level of sedation of thepatient 306 i.e. as determined by the described embodiments.

Conscious Sedation Involving a Hand Motion Patient Response

A fourth aspect of the invention relates to conscious sedation andinvolves a hand motion patient response. Referring now to the drawings,FIG. 4-1 illustrates a first embodiment of the fourth aspect of theinvention. A first expression of the first embodiment is for a conscioussedation system 400 including a controller 402 and a response testingapparatus 404 (wherein parts 404 a and 404 b are parts of the responsetesting apparatus 404). The controller 402 generates a request for apredetermined hand motion response from a patient 406 and analyses atleast a hand motion response made by the patient 406 to the request todetermine a level of sedation of the patient 406. The response testingapparatus 404 includes a request assembly 408 and a response assembly410. The request assembly 408 communicates to the patient 406 therequest generated by the controller 402. The response assembly 410senses the hand motion response and communicates the hand motionresponse to the controller 402.

By “hand motion” is meant translation and/or rotation of a hand of thepatient 406. In some applications of the fourth aspect of the invention,hand motion is translation and/or rotation of the palm of the hand. Suchpalm motion may or may not be accompanied by movement of one or morefingers and/or thumb relative to the palm of the hand. In one variation,such palm motion is substantially without any finger/thumb movementrelative to the palm. Examples of body movement of a patient 406undergoing conscious sedation which results in, or can result in, handmotion include, without limitation, bending of the wrist, rotation ofthe forearm, bending of the elbow, and motion of the upper arm.

In one implementation of the first expression of the embodiment of FIG.4-1, certain patient vital signs such as blood pressure, blood oxygensaturation (oximetry) and inhalation and exhalation carbon dioxidelevels (capnometry) are electronically monitored and are also analyzedby the controller 402, in addition to the response from the responseassembly 410, to determine a level of sedation of the patient. The term“controller”, without limitation, includes one controller and includestwo or more spaced-apart subcontrollers, etc. Examples of requestassemblies 408 in FIG. 4-1 include a handpiece having a vibrator andsecured to the hand of the patient 406 and an earphone speaker disposedin the ear of the patient 406. Other request assemblies includevibrators supported by a blood pressure cuff, supported by a pulseoximeter disposable on a finger or ear lobe of the patient, or supportedby another medical device. Additional request assemblies includevibrators placed upon the face, head, neck, or upper spine of thepatient. In one design, a cable 412 operatively connects the controller402 to the request assembly 408, and a cable 414 operatively connectsthe response assembly 410 to the controller 402.

In one example of the first expression of the embodiment of FIG. 4-1, auser and/or the controller 402 determines a delivery schedule (includingany interruption of delivery) of a conscious-sedation drug to thepatient 406 based at least in part on the determined level of sedationof the patient 406. The drug delivery apparatus has been omitted fromFIG. 4-1 for clarity. A conscious sedation drug is a drug or drugcombination which, in an efficacious amount, is capable of sedating thepatient 406 during a medical procedure (such as a colonoscopy) whilekeeping the patient 406 conscious. Conscious sedation drugs, such asPropofol, are well known in the medical art. In one alternative, a usersuch as a doctor, instead of the controller 402, determines a deliveryschedule of the conscious-sedation drug to the patient 406 based atleast in part on the determined level of sedation of the patient 406.

A first example of the response assembly 410 includes a handpiece 416,as shown in FIG. 4-2, wherein the handpiece 416 sends a signal to thecontroller 402 when the handpiece 416 is moved. In one application, thehandpiece 416 is attachable to the hand of the patient 406, such asthrough use of a band 418. In one variation, the handpiece 416 includesat least one accelerometer 420, 422 and 424 as shown in FIG. 4-3. In onemodification, the handpiece 416 includes three mutually-orthogonalaccelerometers 420, 422 and 424 or tilt sensors. In one usage, thepredetermined hand motion response is a jiggle/shake of the handpiece ofa predetermined distance, velocity and/or acceleration. In anotherusage, the predetermined hand motion response is a movement of thehandpiece along a predetermined path and, optionally, at a predeterminedvelocity and/or acceleration at points along the predetermined path.

In one implementation of the handpiece 416, the controller 402 analyzesat least the position and/or orientation and/or changes therein of thehandpiece 416 to determine the level of sedation of the patient 406. Inthe same or a different implementation, the controller 402 analyzes atleast the velocity of the handpiece 416 to determine the level ofsedation of the patient 406. In the same or a different implementation,the controller 402 analyzes at least the acceleration of the handpiece416 to determine the level of sedation of the patient 406. In onevariation, the controller 402 analyzes at least two of the position, thevelocity, and the acceleration of the handpiece 416 to determine thelevel of sedation of the patient 406. In one modification, thecontroller 402 analyzes at least the position, the velocity, and theacceleration of the handpiece 416 to determine the level of sedation ofthe patient 406. In one application, the controller 402 creates a timepath of the movement of the handpiece 416 and compares the deviation ofthat time path from a predetermined time path of the predetermined handmotion response to determine the level of sedation of the patient 406.

In one construction of the handpiece 416, the handpiece 416 includesother types of motion sensors or position sensors in place of or inaddition to an accelerometer-type of motion sensor. Such other motionsensors include tilt sensors, micromachined gyroscopes, compasses, etc.Such other position sensors include a telemetry transponder, etc.

In one employment of the first expression of the embodiment of FIG. 4-1,the predetermined hand motion response is the patient 406 moving a handtoward another part of the body. In one variation, the hand (such as thehand including an extended finger) is moved toward the nose. In onemodification, the response assembly 410 includes a proximity sensor (notshown) which sends a signal to the controller 402 when the distancebetween the hand (such as the distance of the extended finger of thehand) and the nose is within a predetermined distance. Such signal isused by the controller to indicate that the patient 406 is at a level ofconsciousness defined, at least in part, by the predetermined“hand-to-body-part” hand motion response. In a different employment, thepredetermined hand motion response is the patient 406 moving a hand(such as the hand including an extended finger) to trace out a figuresuch as the figure “8”. In one modification, the response assembly 410includes one or more accelerometers 420, 422 and 424 whose output(s) isused by the controller 402 in determining if the hand motion response isclose enough to the predetermined hand motion response to indicate thatthe patient 406 is at a level of consciousness defined, at least inpart, by the predetermined “figure-tracing” hand motion response.

In one combination of hand motion requests, the controller 402 makes tworequests. One request is for the patient 406 to move a hand towardanother part of the body. The other request is for the patient 406 tomove a hand to trace out a figure. The controller 402 at least analyzesthe responses from the two requests to determine the level of sedationof the patient. In one example, a patient who passes the“figure-tracing” request but fails the “finger-to-body-part” request isconsidered by the controller 402 (with other inputs used by thecontroller for determining the level of sedation being equal) to be at adeeper level of sedation than a patient who passes both requests.

In an expansion of the fourth aspect of the invention, the response isnot limited to a hand motion response but includes a series of requestsfor different types of predetermined responses. In one employment, suchseries is in an ascending or a descending order of difficulty for apatient to give an acceptable (i.e., acceptable as determined by thecontroller 402) response. The acceptable response for different types ofpredetermined responses corresponds (with other inputs used by thecontroller for determining the level of sedation being equal) todifferent levels of sedation of the patient. One example of such aseries includes requests for: “figure tracing”, “hand-to-body-part”,switch activation on a handpiece within a predetermined time since therequest, double-clicking a button on a handpiece within a predeterminedtime interval, and any movement of a handpiece. Other examples are leftto the artisan.

A second expression of the embodiment of FIG. 4-1 is for a conscioussedation system 400 including a controller 402 and a response testingapparatus 404. The controller 402 generates a request for apredetermined hand motion response from a patient 406, analyses at leasta hand motion response made by the patient 406 to the request todetermine a level of sedation of the patient 406, and generates afeedback signal which is communicated (in one example by a “clicker” 426in the handpiece 416) to the patient 406 when the hand motion responsefrom the patient 406 meets a predetermined criteria. The responsetesting apparatus 404 includes a request assembly 408 and a responseassembly 410. The request assembly 408 communicates to the patient 406the request generated by the controller 402. The response assembly 410senses the hand motion response and communicates the hand motionresponse to the controller 402.

In one example of the second expression of the embodiment of FIG. 4-1,the controller 402 changes the predetermined criteria between tworequests and at least analyzes the responses from the two requests todetermine the level of sedation of the patient 406. For example, apatient 406 who passes a two-inch proximity criteria for a hand to noserequest but fails a one-inch proximity criteria is considered by thecontroller 402 (with other inputs used by the controller for determiningthe level of sedation being equal) to be at a deeper level of sedationthan a patient who passes both criteria.

A third expression of the embodiment of FIG. 4-1 is for a responsetesting apparatus 404 for a conscious sedation system 400. The responsetesting apparatus 404 includes a request assembly 408 and a responseassembly 410. The request assembly 408 communicates to a patient 406 arequest generated by a controller 402 of the conscious sedation system400 for a predetermined hand motion response from the patient 406. Theresponse assembly 410 senses a hand motion response made by the patient406 to the request and communicates the hand motion response to thecontroller 402 which analyzes at least the hand motion response todetermine a level of sedation of the patient 406.

In one example of the third expression of the embodiment of FIG. 4-1,the response assembly 410 senses at least one of a translation and arotation of the hand of the patient 406.

A first example of the response assembly 410 includes a motion detector(such as an accelerometer 420, 422 and 424) supportable by the hand ofthe patient 406 (such as by using a handpiece 416).

A second example of the response assembly 410, shown in FIG. 4-4,includes a telemetry tracking system 428 for tracking hand motion of thepatient 406. In one construction, the telemetry tracking system 428includes a transponder 430 attachable to the hand of the patient 406. Inone variation, the transponder 430 is attachable to a finger of the handwherein the patient has been told, in making the predetermined handmotion response, to move the hand without moving the finger relative tothe palm of the hand. In this construction, the telemetry trackingsystem 428 additionally includes three receivers 432 wherein eachreceiver receives a signal from the transponder 430 as is understood bythe artisan.

A third example of the response assembly 410, shown in FIG. 4-5,includes a touch pad 434 disposable proximate the hand of the patient406. In one variation, the touch pad 434 is disposed on the hospital bedoccupied by the patient 406. Other locations for the touch pad 434 areleft to the artisan. In one construction, the touch pad converts handcontact of the patient 406 to position information of the touched siteon the touch pad 434 and communicates such positional information to thecontroller 402.

Advantages and benefits of one or more of the expressions of theembodiment and examples, etc. of FIGS. 4-1 to 4-5 include a finerdetermination of the level of sedation of a patient undergoing a medicalprocedure involving conscious sedation. Also, hand motion responses areeasier for a patient undergoing conscious sedation to make thanactivating a switch on a handpiece. It is noted that hand motionresponses do not require grip strength and are easier for patients tomake whose grip strength is impaired. Eliminating switches provides forgreater reliability as switches need to be sealed against moisture anddebris.

Conscious Sedation Involving Dynamics of a Hand Grip Patient Response

A fifth aspect of the invention relates to conscious sedation andinvolves the dynamics of a hand grip patient response. Referring now tothe drawings, FIG. 5-1 illustrates a first embodiment of the fifthaspect of the invention. A first expression of the first embodiment isfor a conscious sedation system 500 including a controller 502 and aresponse testing apparatus 504 (wherein parts 504 a and 504 b are partsof the response testing apparatus 504). The controller 502 generates arequest for a predetermined hand grip response from a patient 506 andanalyses at least a dynamic variable of a hand grip response made by thepatient 506 to the request to determine a level of sedation of thepatient. The response testing apparatus 504 includes a request assembly508 and a response assembly 510. The request assembly 508 communicatesto the patient 506 the request generated by the controller 502. Theresponse assembly 510 senses the dynamic variable of the hand gripresponse and communicates the dynamic variable to the controller 502.

By “hand grip response” is meant the response of a patient using a hand,or one or more fingers and/or a thumb thereof, to squeeze or exertpressure. Examples of a hand grip response include, without limitation,a patient using a hand to squeeze or try to squeeze a handpiece and apatient using a finger to depress a plunger. By “sensing a dynamicvariable” is meant sensing the varying value of a dynamic variable. A“dynamic variable” includes, without limitation, applied force (orpressure), the time rate of the applied force (or pressure), thedistance moved, the velocity of movement, and the acceleration ofmovement. A “dynamic variable” does not include a switch which is eitheractivated or not activated and does not include the time between arequest and a response or the time between two responses.

In one implementation of the first expression of the embodiment of FIG.5-1, certain patient vital signs such as blood pressure, blood oxygensaturation (oximetry) and inhalation and exhalation carbon dioxidelevels (capnometry) are electronically monitored and are also analyzedby the controller 502, in addition to the response from the responseassembly 510, to determine a level of sedation of the patient. The term“controller”, without limitation, includes one controller and includestwo or more spaced-apart subcontrollers, etc. Examples of requestassemblies 508 in FIG. 5-1 include a handpiece having a vibrator andsecured to the hand of the patient 506 and an earphone speaker disposedin the ear of the patient 506. Other request assemblies includevibrators supported by a blood pressure cuff, supported by a pulseoximeter disposable on a finger or ear lobe of the patient, or supportedby another medical device. Additional request assemblies includevibrators placed upon the face, head, neck, or upper spine of thepatient. In one design, a cable 512 operatively connects the controller502 to the request assembly 508, and a cable 514 operatively connectsthe response assembly 510 to the controller 502.

In one example of the first expression of the embodiment of FIG. 5-1, auser and/or the controller 502 determines a delivery schedule (includingany interruption of delivery) of a conscious-sedation drug to thepatient 506 based at least in part on the determined level of sedationof the patient 506. The drug delivery apparatus has been omitted fromFIG. 5-1 for clarity. A conscious sedation drug is a drug or drugcombination which, in an efficacious amount, is capable of sedating thepatient 506 during a medical procedure (such as a colonoscopy) whilekeeping the patient 506 conscious. Conscious sedation drugs, such asPropofol, are well known in the medical art. In one alternative, a usersuch as a doctor, instead of the controller 502, determines a deliveryschedule of the conscious-sedation drug to the patient 506 based atleast in part on the determined level of sedation of the patient 506.

In one design of the first expression of the embodiment of FIG. 5-1, theresponse assembly 510 senses a nerve signal sent by the brain of thepatient 506 to activate a muscle which is used by the patient 506 tomake a hand grip response. In one variation, one or more electrodes areapplied to the hand, wrist, etc. and are monitored for EMG(electromyography) or other neural activity, wherein, in one embodiment,the electrodes are part of a handpiece. In one modification, the EMGactivity/intensity, when the patient squeezes a handpiece, is consideredby the controller 502 to be proportional to the level of sedation of thepatient (with other inputs used by the controller in determining thelevel of sedation being equal), as can be appreciated by those skilledin the art. It is noted that the electrode can detect a weak attempt ofthe patient to make a hand grip response, including a patient responsewith no detectable movement but detectable muscle fiber firing.

In another design of the first expression of the embodiment of FIG. 5-1,the response assembly 510 includes a handpiece 516, as shown in FIG.5-2. The handpiece 516 is disposable in a hand of the patient 506. Thehandpiece 516 senses the dynamic variable of the hand grip response andcommunicates the dynamic variable to the controller 502. In oneapplication, the handpiece 516 is attachable to the hand of the patient506, such as through use of a band 518.

In one arrangement, the handpiece 516 senses the force of the hand gripresponse. In one construction, the handpiece 516 includes a force sensor520 as shown in FIG. 5-3, wherein the controller 502 at least analyzesat least one of the amount of force of the hand grip response and thetime variation of the amount of force of the hand grip response todetermine the level of sedation of the patient 506. Force sensors 520include, without limitation, a strain gauge, a variable force resistor,and a piezo device as can be appreciated by the artisan. Force sensorscan be placed on or in the handpiece to react to a squeeze of the handand can be placed in the handpiece to react to the finger or thumbdisplacement of a plunger.

In the same or a different construction, the handpiece 516 includes adisplacer 522, and the controller 502 at least analyzes at least one ofthe distance that the displacer 522 is moved, the velocity of thedisplacer 522, and the acceleration of the displacer 522 to determinethe level of sedation of the patient 506. In one variation, thecontroller 502 analyzes at least two of the distance, the velocity, andthe acceleration of the displacer 522 to determine the level of sedationof the patient 506. In one modification, the controller 502 analyzes atleast the distance, the velocity, and the acceleration of the displacer522 to determine the level of sedation of the patient 506. In oneapplication, the displacer 522 is a finger or thumb displaced plunger524 wherein the plunger is spring loaded, otherwise equipped, to returnto its original non-depressed position when the patient is notdisplacing the plunger.

In one enablement of the first expression of the embodiment of FIG. 5-1,the controller 502 generates a feedback signal which is communicated (inone example by a “clicker” 526 (such as, for example, a solenoid ordisplaceable diaphragm) in the handpiece 516) to the patient 506 whenthe hand grip response from the patient 506 meets a predeterminedcriteria.

In the same or a different enablement, the controller 502 changes thepredetermined criteria between two requests and at least analyzes thehand grip responses from the two requests to determine the level ofsedation of the patient 506. For example, a patient 506 who passes atwo-millimeter per second velocity criteria for a finger displacedplunger 524 but fails a four-millimeter per second velocity criteria isconsidered by the controller 502 (with other inputs used by thecontroller for determining the level of sedation being equal) to be at adeeper level of sedation than a patient who passes both criteria.

In the same or a different enablement, the handpiece 516 is adjustable(or automatically adapts) in compliance and/or size to respond to one ofa lower hand grip force and/or size and a higher hand grip force and/orsize. This enables the same handpiece 516 to be used by a patient havinga weak grip and by a patient having a strong grip. In one variation, amotor (not shown) having an adjustable biasing voltage resists themotion of the plunger 524, wherein the biasing voltage is set low torespond to a patient with a weaker grip (e.g., one to five pounds ofhand grip force) and is set high to respond to a patient with a strongergrip (e.g., twenty to thirty pounds of hand grip force). In onemodification, a high-to-low resistance adjustment is made to take placewhen the patient 506 reaches an acceptable hand grip response so thatthe following “collapse” of the handpiece 516 acts as a feedback to thepatient 506 indicating a successful hand grip response.

A second expression of the embodiment of FIG. 5-1 is for a responsetesting apparatus 504 for a conscious sedation system 500. The responsetesting apparatus 504 includes a request assembly 508 and a responseassembly 510. The request assembly 508 communicates to a patient 506 arequest generated by a controller 502 of the conscious sedation system500 for a predetermined hand grip response from the patient 506. Theresponse assembly 510 senses a dynamic variable of a hand grip responsemade by the patient 506 to the request and communicates the dynamicvariable to the controller 502 which analyzes at least the dynamicvariable to determine a level of sedation of the patient 506.

In one example of the second expression, the dynamic variable is chosenfrom the group consisting of the amount of force of the hand gripresponse, the time variation of the amount of force of the time gripresponse, the distance of the hand grip response, the velocity of thehand grip response, and the acceleration of the hand grip response. Inone variation, the response assembly 510 senses the amount of force ofthe hand grip response, and the controller 502 calculates the timevariation of the amount of force of the time grip response. In the sameor a different variation, the response assembly 510 senses the distanceof the hand grip response, and the controller 502 calculates thevelocity (i.e., the time variation of the distance) and/or theacceleration (i.e., the time variation of the velocity).

In the same or a different example, a user and/or the controller 502determines a delivery schedule of a conscious-sedation drug to thepatient 506 based at least in part on the determined level of sedationof the patient.

A third expression of the embodiment of FIG. 5-1 is for a responseassembly 510 for a response testing apparatus 504 for a conscioussedation system 500, wherein the response testing apparatus 504 includesa request assembly 508 which communicates to a patient 506 a requestgenerated by a controller 502 of the conscious sedation system 500 for apredetermined hand grip response from the patient 506. The responseassembly 510 includes a handpiece 516 which senses a dynamic variable ofa hand grip response made by the patient 506 to the request and whichcommunicates the dynamic variable to the controller 502 which analyzesat least the dynamic variable to determine a level of sedation of thepatient 506.

In one example of the third expression of the embodiment of FIG. 5-1,the response assembly 510 includes a resistance handpiece 528 (seen inFIG. 54) which includes an electrical resistance sensor 530 having twoelectrodes 532 and 534 each contactable with the skin of the patient 506(or a conductive glove worn by the patient) when the patient grips theresistance handpiece 528, wherein the skin (or glove) exerts a variablepressure on the two electrodes 532 and 534 during the hand gripresponse. For purposes of describing the invention, the term“resistance” includes “impedance”. It is noted that the “electricalcircuit” whose resistance is being measured is the skin path (i.e., thegalvanic skin response) of the patient 506 between the two electrodes532 and 534. As the patient 506 grips the resistance handpiece 528 witha stronger force, more of the skin contacts the two electrodes 532 and534 which changes the electrical resistance as measured by theelectrical resistance sensor 530. In one variation, at least one of thetwo electrodes 532 and 534 has a surface roughness between and including10,000 and 50,000 micro-inches.

In another example of the third expression of the embodiment of FIG.5-1, the response assembly 510 includes a capacitance handpiece 536(seen in FIG. 5-5) which includes an electrical capacitance sensor 538and two conductors 540 and 542, wherein the hand grip response causesthe distance between the two conductors 540 and 542 to vary. In afurther example, the handpiece has a proximity sensor which detects thedistance between two elements which changes as the handpiece issqueezed, and wherein the hand grip response causes the distance betweenthe two elements to vary.

In an additional example of the third expression of the embodiment ofFIG. 5-1, the response assembly 510 includes an air-bladder handpiece544 (seen in FIG. 5-6) which includes a compliant air bladder 546,wherein the controller 502 analyzes at least the air pressure within theair bladder 546 to determine the level of sedation of the patient 506.In one variation, the air-bladder handpiece 544 includes a pressuresensor 548 which is disposed within the air bladder 546 and which sendsa signal to the controller 502 corresponding to the air pressure withinthe air bladder 546. In an extension of the air-bladder concept, notshown, the air-pressure-movable protrusion of a thin area of the airbladder is used to activate a switch to signal the controller that ahand grip response has been made by the patient.

Advantages and benefits of one or more of the expressions of theembodiment and examples, etc. of FIGS. 5-1 to 5-6 include a finerdetermination of the level of sedation of a patient undergoing a medicalprocedure involving conscious sedation. In one application, the changein the determined levels of sedation over time (i.e., the rate ofsedation) is computed and used to predict the level of sedation at afuture time. The motor-biased handgrip example allows a handgrip to beadjusted to accommodate the different grip strengths of differentpatients. In those examples which eliminate external switches, suchswitch elimination provides for greater reliability as switches need tobe sealed against moisture and debris.

Conscious Sedation Involving a Non-Ear-Canal-Contacting Speaker

A sixth aspect of the invention relates to conscious sedation andinvolves a non-ear-canal-contacting speaker. Referring now to thedrawings, FIG. 6-1 illustrates a first embodiment of the sixth aspect ofthe invention. A first expression of the first embodiment is for aconscious sedation system 600 including a controller 602 and a responsetesting apparatus 604 (wherein parts 604 a and 604 b are parts of theresponse testing apparatus 604). The controller 602 generates a requestfor a predetermined response from a patient 606 and analyses at least aresponse made by the patient 606 to the request to determine a level ofsedation of the patient 606. The response testing apparatus 604 includesa request assembly 608 and a response assembly 610. The request assembly608 audibly communicates to the patient 606 the request generated by thecontroller 602 and includes a non-ear-canal-contacting speaker 612. Theresponse assembly 610 senses the response and communicates the responseto the controller 602.

In one construction, a cable 611 operatively connects the controller 602to the request assembly 608 and a cable 613 operatively connects theresponse assembly 610 to the controller 602. In one variation, theresponse assembly 610 includes a handpiece (not shown) which senses aresponse of the patient to the request (such as sensing the patientpushing a button or moving the handpiece). In another variation, theresponse assembly 610 includes a sound detector (e.g., a microphone)which senses a vocal response made by the patient to the request (suchas sensing the patient speaking). Other variations of the responseassembly 610 are left to the artisan.

In one example of the speaker 612 of FIG. 6-1, the speaker 612 is afirst speaker 614 as shown in FIG. 6-2. The first speaker 614, whendisposed on the patient 606 proximate a bone of the patient 606, audiblycommunicates the request to the patient 606 at least in part by boneconduction of audible sound.

A first method of the invention, employing the first speaker 614, is foraudibly communicating to a patient 606 a request generated by acontroller 602 of a conscious sedation system 600 for a predeterminedresponse from the patient 606, wherein the controller 602 analyzes atleast a response made by the patient 606 to the request to determine alevel of sedation of the patient 606. One step includes obtaining afirst speaker 614. Another step includes disposing the first speaker 614proximate a bone of the patient 606. An additional step includes audiblycommunicating to the patient 606 the request made by the controller 602at least in part by bone conduction of audible sound using the firstspeaker 614.

In one employment of the first method, the first speaker 614 is disposedupon the skin or scalp of the patient 606 in the mastoid or skull areaor elsewhere such as the neck or shoulder area. The first speaker 614,utilizing an acoustic transducer vibrator, provides vibration/sound inthe audible frequency range. The sounds are perceived primarily by thepatient 606 via bone conduction which bypasses the tympanic membrane ofthe ear and directly vibrates the cochlea of the ear for the patient 606to hear the sounds.

In another example of the speaker 612 of FIG. 6-1, the speaker 612 is asecond speaker 616 as shown in FIG. 6-3. In this example, the requestassembly 608 also includes a pillow 618, wherein the second speaker 616is disposed in the pillow 618. In one variation, an acoustic couplinggel 638 is disposed in the pillow 618. The cable 611 is also shown inFIG. 6-3.

A second method of the invention, employing the second speaker 616, isfor audibly communicating to a patient 606 a request generated by acontroller 602 of a conscious sedation system 600 for a predeterminedresponse from the patient 606, wherein the controller 602 analyzes atleast a response made by the patient 606 to the request to determine alevel of sedation of the patient 606. One step includes obtaining asecond speaker 616. Another step includes obtaining a pillow 618. Anadditional step includes disposing the second speaker 616 in the pillow618. A further step is disposing the pillow 618 proximate the head ofthe patient 606. An added step includes audibly communicating to thepatient 606 the request made by the controller 602 using the secondspeaker 616.

In an additional example of the speaker 612 of FIG. 6-1, the speaker 612is a third speaker 620 as shown in FIG. 6-4. In this example, therequest assembly 608 also includes a skull cap 622. The third speaker620 is attached to the outside of the skull cap 622. When the skull cap622 is worn on the head of the patient 606, the inside of the skull cap622 covers an ear of the patient 606 and the third speaker 620 issubstantially aligned with the ear canal of the patient 606.

A third method of the invention, employing the third speaker 620, is foraudibly communicating to a patient 606 a request generated by acontroller 602 of a conscious sedation system 600 for a predeterminedresponse from the patient 606, wherein the controller 602 analyzes atleast a response made by the patient to the request to determine a levelof sedation of the patient 606. One step includes obtaining a thirdspeaker 620. Another step includes obtaining a skull cap 622. Anadditional step includes attaching the third speaker 620 to the outsideof the skull cap 622 so that, when the skull cap 622 is worn on the headof the patient 606, the inside of the skull cap 622 covers an ear of thepatient 606 and the third speaker 620 is substantially aligned with theear canal of the patient 606. A further step is disposing the skull cap622 on the head of the patient 606. An added step includes audiblycommunicating to the patient 606 the request made by the controller 602using the third speaker 620.

In a further example of the speaker 612 of FIG. 6-1, the speaker 612 isa fourth speaker 624 as shown in FIG. 6-5. In this example, the requestassembly 608 also includes a skull cap 626 and a tube connector 628attached to the outside of the skull cap 626 as shown in FIGS. 6-5 and6-6. The tube connector 628 includes a sound-tube attachment site 630and includes a sound passageway 632 extending from the outside of theskull cap 626 to the sound-tube attachment site 630. In one design, asound tube 634 is operatively connected to the fourth speaker 624 and tothe sound-tube attachment site 630. Other examples of anon-ear-canal-contacting speaker 612 are left to the artisan andinclude, without limitation, a hospital-bed-supported speaker and afloor-stand-supported speaker.

A fourth method of the invention, employing the fourth speaker 624, isfor audibly communicating to a patient 606 a request generated by acontroller 602 of a conscious sedation system 600 for a predeterminedresponse from the patient 606, wherein the controller 602 analyzes atleast a response made by the patient 606 to the request to determine alevel of sedation of the patient 606. One step includes obtaining afourth speaker 624. Another step includes obtaining a skull cap 626 anda tube connector 628 attached to the outside of the skull cap 626,wherein the tube connector 628 includes a sound-tube attachment site 630and a sound passageway 632 extending from the outside of the skull cap626 to the sound-tube attachment site 630, and wherein, when the skullcap 626 is worn on the head of the patient 606, the inside of the skullcap 626 covers an ear of the patient 606 and the sound passageway 632 atthe outside of the skull cap 626 is substantially aligned with the earcanal of the patient 606. An additional step includes obtaining a soundtube 634. A further step includes operatively connecting the sound tube634 to the fourth speaker 624 and to the sound-tube attachment site 630.Yet another step is disposing the skull cap 626 on the head of thepatient 606. An added step includes audibly communicating to the patient606 the request made by the controller 602 using the fourth speaker 624.

A second expression of the embodiment of FIG. 6-1 is for a requestassembly 608 for a response testing apparatus 604 for a conscioussedation system 600, wherein the conscious sedation system 600 includesa controller 602 which generates a request for a predetermined responsefrom a patient 606. The request assembly 608 includes anon-ear-canal-contacting speaker 612 which audibly communicates to thepatient 606 the request generated by the controller 602.

In one example of the second expression of the embodiment of FIG. 6-1,the speaker 612 is a first speaker 614 as shown in FIG. 6-2. In thisexample, the first speaker 614, when disposed on the patient 606proximate a bone of the patient 606, audibly communicates the request tothe patient 606 at least in part by bone conduction of audible sound. Inone implementation utilizing the first speaker 614, the request assembly608 also includes a headband 636, the first speaker 614 is attached tothe headband 636, and, when the headband 636 is worn by the patient 606,the first speaker 614 contacts a side of the head of the patient 606above the ear. In another implementation, the first speaker 614 isattached to the patient using double-sided adhesive tape or anelastomeric band or a metallic band. In one construction, the firstspeaker 614 is devoid of any sound-emitting opening.

In another example of the second expression, the speaker 612 is a secondspeaker 616 as seen in FIG. 6-3. In this example, the request assembly608 also includes a pillow 618, and the second speaker 616 is disposedin the pillow 618. In one variation, the request assembly 608 alsoincludes an acoustic coupling gel 638 or an elastomeric pad disposed inthe pillow 618. Examples of acoustic coupling gels 638 are left to theartisan. In one utilization, when the head of the patient 606 isdisposed against the pillow 618, the sound path between the secondspeaker 616 and the ear of the patient 606 is substantially defined bythe acoustic coupling gel 638. In one modification, the request assembly608 also includes a single-use pillow cover (not shown) which covers thepillow 618 and which is exchanged with another single-use pillow coverbefore use by the next patient.

In an additional example of the second expression, the speaker 612 is athird speaker 620 as seen in FIG. 6-4. In this example, the requestassembly 608 also includes a skull cap 622, the third speaker 620 isattached (either fixedly attached or removably attached such as withadhesive tape) to the outside of the skull cap 622, and, when the skullcap 622 is worn on the head of the patient 606, the inside of the skullcap 622 covers an ear of the patient 606 and the third speaker 620 issubstantially aligned with the ear canal of the patient 606. In oneimplementation utilizing the third speaker 620, the request assembly 608also includes a cable connector 640 (such as a socket or a plug)attached (either fixedly attached or removably attached such as withadhesive tape) to the outside of the skull cap 622 and includes a cord642 operatively connecting (such as being hard wired to) the cableconnector 640 and the third speaker 620. In another variation, notshown, the cord 642 is omitted and the cable connector 640 is attacheddirectly to the third speaker 620. In one arrangement, the requestassembly 608 also includes a cable 611, wherein the cable 611 isoperatively connectable to the controller 602 (such as being hard wiredto the controller 602) and to the cable connector 640 (such as beingconnectable to the cable connector 640 via a mating socket/plug 646). Inone extension of the example of the third speaker 620, with or withoutcontact of the third speaker 620 with the ear canal of the patient 606,the skull cap 622 has one or more sound holes (not shown) between thethird speaker 620 and the ear canal of the patient 606.

In a further example of the second expression, the speaker 612 is afourth speaker 624 as seen in FIGS. 6-5 and 6-6. In this example, therequest assembly 608 also includes a skull cap 626 and a tube connector628 attached (either fixedly attached or removably attached such as withadhesive tape) to the outside of the skull cap 626. In this example, thetube connector 628 includes a sound-tube attachment site 630 andincludes a sound passageway 632 extending from the outside of the skullcap 626 to the sound-tube attachment site 630. In one implementation,when the skull cap 626 is worn on the head of the patient 606, theinside of the skull cap 626 covers an ear of the patient 606 and thesound passageway 632 at the outside of the skull cap 626 issubstantially aligned with the ear canal of the patient 606. In onearrangement, the request assembly 608 also includes a sound tube 634,wherein the sound tube 634 is operatively connectable to the fourthspeaker 624 and to the sound-tube attachment site 630. In one variation,the skull cap 626 has one or more sound holes (not shown) between thetube connector 628 and the ear canal of the patient 606. In anothervariation, the skull cap 626 is omitted and the end of the sound tube634 distant the fourth speaker 624 is disposed proximate (including in)the ear canal of the patient.

In one construction involving the third and/or fourth speaker 620/624,the skull cap 622/626 includes a plastic film 648 having a periphery andan elastic band 650 attached to the plastic film 648 proximate theperiphery as found in some shower caps. In an alternate construction,not shown, the skull cap 622/626 has a swimming-cap type ofconstruction. Other constructions are left to the artisan. In oneextension of the third and/or fourth speaker 620-624, with or withoutcontact of the speaker with the ear canal, the third and/or fourthspeaker 620/624 has a food-worker-hair-net type of construction.

A third expression of the embodiment of FIG. 6-1 is for a requestassembly 608 for a response testing apparatus 604 for a conscioussedation system 600, wherein the conscious sedation system 600 includesa controller 602 which generates a request for a predetermined responsefrom a patient 606. The request assembly 608 includes anon-ear-canal-contacting speaker 612/624 which audibly communicates tothe patient 606 the request generated by the controller 602. The requestassembly 608 also includes a sound tube 634 (as seen in FIG. 6-5) havingone end disposable proximate an ear canal or a microphone of anassistive hearing device (such as a hearing aide) of the patient 606 andhaving another end disposable proximate the speaker 612/624. In onevariation, the one end is disposable in the ear canal of the patient606. In one arrangement, the speaker 612/624 is attachable to, orsupportable by, the bed of the patient 606 or by an IV pole.

Any one or more of the previous embodiments, expressions, and methodscan be extended, as appropriate, to provide sound to both ears of thepatient, as can be appreciated by the artisan. In one variation, aswitch or switches are provided to turn on and shut off providing soundto each ear of the patient.

Advantages and benefits of one or more of the expressions (but notnecessarily extensions thereof) of the embodiments of FIGS. 6-1 to 6-6include not having direct contact of the speaker with the ear canal ofthe patient 606. This design eliminates secretions of the ear canal ofthe patient from entering the speaker 612 which otherwise would have tobe cleaned between patient use. Because no device enters the ear canal,this design provides more comfort for the patient and is compatible withpatients with hearing aids. In the example employing the first speaker614, no ear of the patient 606 is covered by any apparatus of therequest assembly 608 adding to patient comfort and allowing the doctorto communicate with the patient, if desired, without having to remove aheadset or an earphone from the ear or ears of the patient. In theexample employing the second speaker 616, embedding a speaker in apillow allows, in one arrangement, use of a replaceable (including asingle-use) pillow cover. Any single-use device eliminates the need forcleaning between patient use. In the example employing the third speaker620, having a skull cap 622 with attached third speaker 620 and cordconnector 640 allows, in one arrangement, a single-use skull cap 622employing an inexpensive or removably-attachable third speaker 620 (andoptionally cord connector 640). In the example employing the fourthspeaker 624, the use of a removably-attachable sound tube 634 to connectwith the skull cap 626 allows, in one arrangement, a single-use skullcap 626 employing an inexpensive or removably-attachable tube connector628. It is noted that a non-ear-canal-contacting speaker accommodateshearing-impaired patients by communicating with an assistive hearingdevice, such as a hearing aid, worn by such patients.

Conscious Sedation Involving Personalized Audio Requests

It is known in conscious sedation that when a patient is sedated andreceives an audio stimulus request, the patient is more responsive tothe audio request when there is a personalized message, the personalizedmessage having a voice, word, phrase or sound with which the patient isfamiliar especially one which has a personal association or isemotionally evoking with the patient. Examples of personalized messagesthat the patient is more responsive to include a message addressing thepatient by his name or a message using a voice that the patient isfamiliar with such as a family member or a doctor. Other examples ofmessages may be sounds that are attention-getting with a particularfocus from the patient's perspective such as a dog bark or a siren.

A seventh aspect of the invention relates a conscious sedation systemwhich generates an audio request with a personalized message. FIG. 7-1illustrates an embodiment of the seventh aspect of the invention. Anembodiment of the invention is for a conscious sedation system 700including a controller 702 and a response testing apparatus 704, whereinthe controller 702 generates a request for a predetermined responsegenerated by the patient 706 to the request, and wherein the controllerincludes an input 712 wherein a personalized message can be included inthe request. The response testing apparatus 704 includes a requestassembly 708 and a response assembly 710. The request assembly 708communicates to the patient 706 the request generated by the controller702, the request having a personalized message. The response assembly710 is used by the patient 706 to generate the response and communicatesthe response to the controller 702.

In an embodiment of the invention, the input 712 can be a keypad ortouch screen or other input device, wherein the patient's information isput into the controller. The keypad or touch screen may contain atext-to-speech software so that the patient's information can beconverted to speech through voice synthesis and included in thepersonalized message. By addressing the sedated patient by name in theform of a personalized message, the patient is more likely to respond tothe request. In addition to addressing the patient by name, thepersonalized message can also include a command such as “please squeezeyour hand” or “please release your hand.” The message can be used toinstruct the patient on how to respond to various audible, tactile orother stimulation encountered during the procedure. Accordingly, thepersonalized message can be a supplement to or part of the request or itcan be the request itself.

Another embodiment is an input that includes a microphone to enter thepatient's information or a message to be included in the personalizedmessage. The microphone further allows voices of specific persons to berecorded into the personalized message. For instance, a the patient'sdoctor or relative or a person to whom the patient is acquainted mayrecord his own voice into a personalized message. In this way, thesedated patient is more likely to respond when he hears the familiarvoice. In a preferred embodiment, the personalized message is recordedand saved as a wav file in the controller memory. The controller canthen output the wav file or a combination of wav files as thepersonalized message. For instance, the controller may combine a wavfile for “mister” or “misses” with a wav file containing the patient'sname incorporating them into a personalized message. In anothermanifestation of the preferred embodiment, voice recognition software isused to convert the patient's name and information into text to bedisplayed on the screen for data entry, which may be manually corrected.The patient's name may be used later for playback as a request. Thepersonalized message can also be manually or automatically revisedduring the procedure to reduce the tendency for the patient to adapt tothe audio stimulus. The personalized message can be adaptedautomatically to change words in accordance with preset selections or inaccordance with the patient's response; For example, the words whichproduce the greatest or most reliable patient response through theprocedure may be used to assure a greater likelihood of getting aresponse as the patient becomes more deeply sedated. Other examples ofpersonalized messages include those that have a directly relevantcontextual tonal message, such as a voice speaking in a unique dialector accent pattern particular to the patient; this provides for enhancedinterest and comprehension versus a more generic version of the samelanguage which leads to more effective audio stimulation. Thepersonalized message may also be linguistically adapted for patientsresiding in specific localities of a region. Finally, the audio stimulusmay also be a sound or song with which the patient is familiar.

In a further embodiment of the invention, the personalized message maybe stored as memory in either the controller or the response testingassembly, wherein the memory is either digital or analog. Thepersonalized message may be transferable from the controller to theresponse testing assembly by cable or wireless means and vice versa. Inone manifestation of an embodiment of the invention, the message may beplayed in accordance with a predetermined time schedule. For example, itmay be synchronized to occur in conjunction with the onset of eachrequest or vibration period or it may utilize an adaptive audiostimulation timing in accordance with the patient's responsiveness suchas not issuing the message unless successive vibrational attempts havefailed to obtain a patient response. This reduces the tendency for thepatient to habituate to the audio stimulation.

In yet a further embodiment of the invention, the input may be anauxiliary input signal connector for the user to input voice or sounddata from an external source such as an external microphone or anexternal audio source. The audio source may be an analog audio sourcesuch as a tape recorder or a digital source such as CD, MP3 etc.Further, the system may include a CD or tape player for accepting inputfrom a storage media that contains components of the personalizedmessage.

In the example of the expression of the embodiment of FIG. 7-1, thecontroller 702 determines a delivery schedule of a conscious sedationdrug to the patient 706 based at least in part on the determined levelof sedation of the patient 706. The drug delivery apparatus has beenomitted from FIG. 7-1 for clarity. A conscious sedation drug is a drugor drug combination which, in an efficacious amount, is capable ofsedating the patient 706 during a medical procedure (such as acolonoscopy) while keeping the patient 706 conscious. Conscious sedationdrugs, such as Propofol, are well known in the medical art. In onealternative, a doctor, instead of the controller 702, determines adelivery schedule of the conscious sedation drug to the patient 706based at least in part on the determined level of sedation of thepatient 706.

Conscious Sedation Using Finger Movement Response Assembly

An eighth aspect of the invention relates to finger movement responsetesting for conscious sedation. FIG. 8-1 illustrates an embodiment ofthe eighth aspect of the invention. An embodiment of the invention isfor a conscious sedation system 800 including a controller 802 and aresponse testing apparatus 804. The controller 802 generates a requestfor a predetermined response from a patient 806 to the request todetermine a level of sedation of the patient 806 The response testingapparatus 804 includes a request assembly 808 and a response assembly810. In a manifestation of the invention, either the response assembly810 or the request assembly 808 is a finger attachable apparatus. Thefinger attachable apparatus can be a response assembly 810 wherein theresponse is generated by the movement of the patient's fingers or thefinger attachable apparatus can be a request assembly 808 wherein therequest is generated via the controller. In a further manifestation thefinger attachable apparatus is both a response assembly and a requestassembly in the response testing apparatus.

In one embodiment of the invention, the finger attachable apparatus is afinger touch response apparatus as shown in FIG. 8-2. The fingerattachable apparatus comprises a first finger receptacle 812 and asecond finger receptacle 814 that are attachable onto the patient'sfingers. The receptacles 812, 814 are connected by a biasing member 816that hold the receptacles 812, 814 apart. The biasing member 816 has astrain gage 822 located in the middle. At the ends of the receptacles812, 814 are electrical contacts 818, 820. The finger touch responseapparatus can be used as a response system, request system or both. As arequest system, the finger receptacles 812, 814 can provide a stimulusto the patient's fingers. As a response system, the patient responds bytrying to bring the receptacles 812, 814 in contact with each other bybringing the fingers together. The receptacles 812, 814 are connected bya biasing member 816 of a predetermined stiffness so that thereceptacles do not inadvertently contact each other and can only contacteach other when a sufficient force is applied by bringing the fingerstogether. At the end of the receptacles are electrical contacts 818, 820that register a response when they are brought in contact with eachother.

In a further embodiment of the invention, the biasing member 816 has astrain gage that measures the amount of force the patient is applying inattempting to contact or contacting the receptacles by bringing thefingers together. Although the patient may not succeed in bringing thereceptacles into contact, the amount of force the patient applies in hisattempt can be measured. The higher the level of sedation of thepatient, the less force he is able to generate in bringing thereceptacles into contact with each other. Accordingly, the amount offorce generated by the patient is correlated with the patient's level ofsedation. Nevertheless, there is a minimum threshold force that thepatient must apply in order for a response to be registered. Once thatthreshold force is exceeded, the strain gage continuously measures theamount of force that is applied. If the minimum threshold force is notmet by the patient, there is no registered response.

In another embodiment of the invention, the finger attachable apparatusin FIG. 8-3 is a handpiece finger curl sensor mechanism 830 wherein themechanism has fixed point sensors comprising finger sensors 834, knucklesensors 836 and a palm stimulation source 838 to detect the curlingmovement of the patient's fingers towards the palm. The sensors areattached along the length of the fingers and the palm to detect thebending motion when the patient curls the fingers towards the palm. Thehandpiece finger curl sensor mechanism can be fitted onto the hand andcomprises sensors that coincide with the fingers, knuckles and palm. Thehandpiece finger curl sensor mechanism 830 can be used as a responsesystem, request system or both. As a request system, the palmstimulation source 838 can provide a stimulus to the patient's hand. Asa response system, the patient responds by curling at least one or morefingers towards the palm or closing his hand over the palm stimulationsource; a response can also be generated by uncurling the at least oneor more finger away from the palm. In a further embodiment of theinvention, the palm stimulation source is in the shape of a cylinder orsphere and is located in the palm of the hand wherein the patientgenerates a response by closing his hand over the palm stimulationsource. The sensors measure the change in distance between the variouslocations on the hand. In yet a further embodiment of the invention, thehandpiece is a glove that fits over the hand. The glove is stretchableso that the fingers are able to be curled towards the palm. The amountof stretch can also be measured by the sensors. The patient's ability tocurl his fingers and/or close his hand diminishes as the patient becomesmore sedated. Accordingly, the amount of finger curl or stretch by thepatient correlates with the level of sedation of the patient.

The sensors of the finger curl sensor mechanism can belinear-displacement sensors (such as magnetometers or inductivesensors), a mercury-filled tube acting as a strain gage, or evenelectrodes monitoring changes in surface impedance. However, it shouldbe noted that the sensors are not limited to the ones mentioned. Thehandpiece finger curl sensor mechanism also can be a glove such as alatex-free Nitrile glove. The response can also be selected from aseries of sensors or from a collective response from various sensors.

In one example of the expression of the embodiment of FIG. 8-1, thecontroller 802 determines a delivery schedule of a conscious sedationdrug to the patient 806 based at least in part on the determined levelof sedation of the patient 806. The drug delivery apparatus has beenomitted from FIG. 8-1 for clarity. A conscious sedation drug is a drugor drug combination which, in an efficacious amount, is capable ofsedating the patient 806 during a medical procedure (such as acolonoscopy) while keeping the patient 806 conscious. Conscious sedationdrugs, such as Propofol, are well known in the medical art. In onealternative, a doctor, instead of the controller 802, determines adelivery schedule of the conscious sedation drug to the patient 806based at least in part on the determined level of sedation of thepatient 806.

Conscious Sedation Involving Automated Audio Calibration

It is known that when a patient is sedated, his ability to discern audiostimulus is reduced. Therefore, in a conscious sedation system, thepatient's ability to discern various levels of audio stimulus correlateswith the patient's level of sedation. The higher the level of audiostimulus required for the patient to discern and generate a response,the more sedated the patient. However, because each patient hasdifferent initial levels of hearing, a baseline level of hearing needsto be established in order to use audio stimulus in assessing thepatient's level of sedation. For example, one non-sedated patient may beable to discern a low level audio stimulus while another non-sedatedpatient may need a higher level of audio stimulus in order to discern orhear the stimulus. Accordingly, a baseline level of hearing needs to beestablished with each individual patient before using audio stimulus ina conscious sedation system to determine the patient's level of sedationby monitoring the patient's response to the audio stimulus.

In the prior art, the patient's baseline, namely the minimum thresholdaudio stimulus level at which the patient is able to hear the audiorequest in order to generate a response, is established manually. Thedoctor manually increases the intensity of the audio stimulus until thepatient hears the stimulus and generates a request. The level ofintensity at which the patient discerns the audio request is thebaseline that will be used to in the conscious sedation system. Oncethis baseline is calibrated, it is used in the conscious sedation systemto assess the level of sedation of the patient.

A ninth aspect of the invention relates to an audio calibration settingfor a conscious sedation system. FIG. 9-1 illustrates an embodiment ofthe ninth aspect of the invention. An embodiment of the invention is fora conscious sedation system 900 including a controller 902 and aresponse testing apparatus 904, wherein the controller 902 is programmedto generate a request for a predetermined response from a patient 906 tothe request, and wherein the controller 902 analyzes the response orlack thereof generated by the patient in order to calibrate thepatient's level of hearing based on the patient's response to therequest to establish a baseline audio stimulus and further to determinea level of sedation of the patient 906. The response testing apparatus904 includes a request assembly 908 and a response assembly 910. Therequest generated can be a discrete or continuous audio stimulus.

Referring to FIG. 9-2, in another embodiment of the invention, a methodfor the automated audio calibration of a patient in a conscious sedationsystem is disclosed wherein the controller 902 generates a request tothe patient, the request being an audio stimulus of very low amplitude.The controller 902 monitors the patient's predetermined response to therequest. If the patient does not respond to the request because theamplitude of the stimuli is too low for the patient to perceive, anotherrequest is generated to the patient, the request being a slightly higheramplitude than the previous request. The process is repeated until thepatient generates a predetermined response to the request. Once theresponse is generated, the controller records the level of stimulus atwhich the patient responded and calibrates the patient's baseline levelof hearing based on the level of stimulus to which the patientresponded. Once the patient's baseline level of hearing is establishedand recorded by the controller, the baseline is used as the initialstimulus level in assessing the level of sedation of the patient.

In a further embodiment of the invention as shown in FIG. 9-3, a methodfor the automated audio calibration of a patient's level of hearing andfurther determining the patient's level of sedation is taught. Once thebaseline stimulus is established, an audio stimulus is generated to thepatient based on the baseline stimulus by applying a first audiostimulus to the patient who has received, is receiving or is about toreceive a conscious sedation drug. The patient is then instructed torespond to the audio stimulus. The patient's response to the audiostimulus is monitored and an additional audio stimulus is applied to thepatient when the patient has received, is receiving or is about toreceive a dose of a conscious sedation drug. The additional audiostimulus can be the same or different as the first audio stimulus. Thepatient's response to the additional audio stimulus is monitored againand the patient's level of sedation is assessed based on the patient'sresponse. The steps of applying additional audio stimulus and monitoringthe patient's response can be repeated to determine the patient's levelof sedation.

Another expression of the embodiment of the invention is for a responsetesting apparatus 904 for a conscious sedation system. Referring to FIG.9-4, the response testing apparatus 904 includes a request assembly 908,a response assembly 910, and a sub-controller 914 wherein thesub-controller 914 calibrates the patient's level of hearing based onthe patient's response to establish a baseline level of hearing. Thesub-controller 914 analyzes the response or lack thereof generated bythe patient 906 in order to calibrate the patient's level of hearingbased on the patient's response or lack thereof to the request toestablish a baseline and further to determine a level of sedation of thepatient 906. The sub-controller 914 monitors the patient's predeterminedresponse to the request. If the patient does not respond to the requestbecause the amplitude of the stimulus is too low for the patient toperceive, another request is generated to the patient, the request beinga slightly higher amplitude than the previous request. The process isrepeated until the patient generates a predetermined response to therequest. Once the response is generated, the sub-controller 914 recordsthe level of stimulus at which the patient responded and calibrates thepatient's baseline level of hearing based on the level of stimulus towhich the patient responded. Once the patient's baseline level ofhearing is established and recorded by the sub-controller, the baselineis used as the initial stimulus level in assessing the level of sedationof the patient.

In one example of the embodiment of FIG. 9-1, the controller 902determines a delivery schedule of a conscious sedation drug to thepatient 906 based at least in part on the determined level of sedationof the patient 906. The drug delivery apparatus has been omitted fromFIG. 9-1 for clarity. A conscious sedation drug is a drug or drugcombination which, in an efficacious amount, is capable of sedating thepatient 906 during a medical procedure (such as a colonoscopy) whilekeeping the patient 906 conscious. Conscious sedation drugs, such asPropofol, are well known in the medical art. In one alternative, adoctor, instead of the controller 902, determines a delivery schedule ofthe conscious sedation drug to the patient 906 based at least in part onthe determined level of sedation of the patient 906.

It is understood that any one or more of the previously-describedaspects, embodiments, expressions of embodiments, examples, methods,etc. can be combined with any one or more of the otherpreviously-described aspects, embodiments, expressions of embodiments,examples, methods, etc. For example, and without limitation, cablelesscommunication can be used in combination with personalized audiorequests, etc.

The foregoing description of several aspects of the invention has beenpresented for purposes of illustration. It is not intended to beexhaustive or to limit the invention to the precise forms and proceduresdisclosed, and obviously many modifications and variations are possiblein light of the above teaching. For example, as would be apparent tothose skilled in the art, the disclosures herein of the conscioussedation systems, components thereof and methods therefor have equalapplication in robotic assisted surgery taking into account the obviousmodifications of such systems, components and methods to be compatiblewith such a robotic system.

1. A conscious sedation system comprising: a) a controller whichgenerates a request for a predetermined response from a patient andwhich analyses at least a response made by the patient to the request todetermine a level of sedation of the patient; and b) a response testingapparatus including: (1) a request assembly which audibly communicatesto the patient the request generated by the controller and whichincludes a non-ear-canal-contacting speaker and a pillow, wherein thespeaker is disposed in the pillow; and (2) a response assembly whichsenses the response and which communicates the response to thecontroller.
 2. A request assembly for a response testing apparatus for aconscious sedation system, wherein the conscious sedation systemincludes a controller which generates a request for a predeterminedresponse from a patient, and wherein the request assembly comprises anon-ear-canal-contacting speaker which audibly communicates to thepatient the request generated by the controller, and a pillow, andwherein the speaker is disposed in the pillow.
 3. The request assemblyof claim 2, also including an acoustic coupling gel disposed in thepillow.
 4. A request assembly for a response testing apparatus for aconscious sedation system, wherein the conscious sedation systemincludes a controller which generates a request for a predeterminedresponse from a patient, and wherein the request assembly comprises: a)a non-ear-canal-contacting speaker which audibly communicates to thepatient the request generated by the controller; and b) a sound tubehaving one end disposable in an ear canal or proximate a microphone ofan assistive hearing device of the patient and having another enddisposable proximate the speaker.
 5. A conscious sedation systemcomprising: a) a controller which generates a request for apredetermined response from a patient and which analyses at least aresponse made by the patient to the request to determine a level ofsedation of the patient; and b) a response testing apparatus including:(1) a request assembly which audibly communicates to the patient therequest generated by the controller and which includes anon-ear-canal-contacting speaker and a skull cap and a tube connectorattached to the outside of the skull cap, wherein the tube connectorincludes a sound-tube attachment site and includes a sound passagewayextending from the outside of the skull cap to the sound-tube attachmentsite; and (2) a response assembly which senses the response and whichcommunicates the response to the controller.
 6. A request assembly for aresponse testing apparatus for a conscious sedation system, wherein theconscious sedation system includes a controller which generates arequest for a predetermined response from a patient, and wherein therequest assembly comprises a non-ear-canal-contacting speaker, whichaudibly communicates to the patient the request generated by thecontroller, and a skull cap, a cable connector attached to the outsideof the skull cap and a cord, wherein when the skull cap is worn on thehead of the patient, the inside of the skull cap covers an ear of thepatient and the cord operatively connects the speaker to the cableconnector.
 7. The request assembly of claim 6, also including a cable,wherein the cable is operatively connectable to the controller and tothe cable connector.
 8. The request assembly of claim 6, wherein theskull cap includes a plastic film having a periphery and an elastic bandattached to the plastic film proximate the periphery.
 9. A requestassembly for a response testing apparatus for a conscious sedationsystem, wherein the conscious sedation system includes a controllerwhich generates a request for a predetermined response from a patient,and wherein the request assembly comprises a non-ear-canal-contactingspeaker, which audibly communicates to the patient the request generatedby the controller, and a skull cap and a tube connector attached to theoutside of the skull cap, wherein the tube connector includes asound-tube attachment site and includes a sound passageway extendingfrom the outside of the skull cap to the sound-tube attachment site. 10.The request assembly of claim 9, wherein, when the skull cap is worn onthe head of the patient, the inside of the skull cap covers an ear ofthe patient and the sound passageway at the outside of the skull cap issubstantially aligned with the ear canal of the patient.
 11. The requestassembly of claim 10, also including a sound tube, wherein the soundtube is operatively connectable to the speaker and to the sound-tubeattachment site.
 12. The request assembly of claim 9, wherein the skullcap includes a plastic film having a periphery and an elastic bandattached to the plastic film proximate the periphery.